Wednesday, April 16, 2008

Ghost writing - a dying practice

The practice of "ghost writing" seems to be dying quickly. Merck is being heavily scrutinized because of everything that happened with Vioxx, and this week, JAMA has published some case studies about this very practice.

What does all this mean for those medical communication companies that develop articles for publication in peer-reviewed journals? Well, for starters, all author information will need to be fully disclosed in every publication. We've started to see this in several journals. Clinicians are listing and acknowledging the names of writers who may be employed by medical communications companies. However, some proponents are arguing that medical communications companies should not even be involved in writing any of the content for these manuscripts. Does this mean that professional medical writers may need to start looking for other opportunities?

The buzzword these days is "transparency." Companies and clinicians must fully disclose all relevant information and be completely transparent. This is happening in the world of CME. Professional education that is CME certified should be fair-balanced, free of bias, and evidence-based. All faculty members who develop or present CME programs are required to fully disclose all affiliations that may potentially influence of bias their message.

Transparency is being taken a step further these days. In a bold move, Lilly began a new CME grant transparency process and started posting data about their CME dollars. People can see how Lilly is spending CME dollars. Take a look at their grant office registry report:

The buzzword "transparency" will continue to permeate industry. The FDA, the OIG, and all other stakeholders will demand full transparency whenever research is published. Perhaps those ghost writing companies will need to refocus and find other opportunities...

1 comment:

  1. Published on

    The Human Injury of Lost Objectivity

    If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others, yet sponsored by a pharmaceutical company, would be at the top of the list. By this atrophy of the scientific method absent of authenticity, harm and damage is possibly done to the health of the public. Most would agree that the science of research should be sound and sterile that is completely free of interference. However, it appears, money and increased profits can be a catalyst for reckless disregard for human health that is largely unregulated.
    Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds.

    Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations that are often composed of community patient care clinics. Because of this structure, investigators of these trials are likely void of necessary research experience or quality regarding their research purpose and ability to ensure its sterility. These quite numerous CROS are for- profit, with some CROs making billions of dollars a year.

    The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in the trial. Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for the studied drug of thiers. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner ensures favorable results of the sponsor’s medication. Their activities are again believed to be absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.

    Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known as ghostwriters. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked by the hired author.
    To have the trial published, the sponsor has been known to pay a journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks. The purchased reprints bought by the sponsor of the study are distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation. As a bonus, the sponsor may pay this journal to advertise their products to be placed in this journal as well.
    Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns.. If so, our health care treatment options with meds are now undetermined in large part due to such corruptive situations, as well as the absence of objectivity that has been intentionally eliminated with trials produced in this way. Trust in the scientific method in this type of activity illustrated in this article is absent.

    More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.

    Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, which would require independent clinical trial sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters.

    Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.

    “Ethics and Science need to shake hands.” ……. Richard Cabot

    Dan Abshear

    Author’s note: What has been written was based upon information and belief.